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Clinical Trial of Efficacy and Safety of Subetta in the Combined Treatment of Patients With Type II Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01868646
Recruitment Status : Completed
First Posted : June 4, 2013
Results First Posted : March 4, 2019
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
Materia Medica Holding

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition Type II Diabetes Mellitus
Interventions Drug: Subetta
Drug: Placebo
Enrollment 190
Recruitment Details  
Pre-assignment Details

Selection procedures were carried out after participant enrollment to determine whether the patient could participate in the study in accordance with the inclusion/exclusion criteria.

Of the 190 patients enrolled, 42 did not meet inclusion criteria after screening procedures, they were not randomized

Arm/Group Title Subetta Placebo
Hide Arm/Group Description

Standard therapy of type II diabetes mellitus + Subetta (1 tablet 4 times a day).

Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).

One tablet contains: affinity purified antibodies to the C-terminal fragment of the beta subunit receptor insulin - 0.006g*, affinity purified antibodies to endothelial NO synthase - 0.006g*.

*applied onto isomalt crystals as a mixture of three active aqueous-alcoholic dilutions of the drug substance - diluted 100^12, 100^30, 100^200 times, respectively.

Excipients: isomalt, crospovidone, magnesium stearate.

Standard therapy of type II diabetes mellitus + Placebo (1 tablet 4 times a day).

Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).

Placebo

Period Title: Overall Study
Started 76 72
Completed 73 67
Not Completed 3 5
Reason Not Completed
Do not meet inclusion criteria             3             5
Arm/Group Title Subetta Placebo Total
Hide Arm/Group Description

Standard therapy of type II diabetes mellitus + Subetta (1 tablet 4 times a day).

Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).

Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type II diabetes mellitus

Standard therapy of type II diabetes mellitus + Placebo (1 tablet 4 times a day).

Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 73 67 140
Hide Baseline Analysis Population Description
Intention-to-Treat set
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 73 participants 67 participants 140 participants
57.9  (7.1) 57.3  (6.2) 57.6  (6.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants 67 participants 140 participants
Female
59
  80.8%
54
  80.6%
113
  80.7%
Male
14
  19.2%
13
  19.4%
27
  19.3%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 73 participants 67 participants 140 participants
85.7  (13.0) 89.0  (11.7) 87.1  (12.5)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter
Number Analyzed 73 participants 67 participants 140 participants
164.1  (7.7) 165.3  (7.3) 164.7  (7.5)
BMI  
Mean (Standard Deviation)
Unit of measure:  Kilogram/m^2
Number Analyzed 73 participants 67 participants 140 participants
31.7  (4.0) 32.5  (3.6) 32.1  (3.8)
1.Primary Outcome
Title Changes in the Mean Value of HbA1c
Hide Description The HbA1C test was performed using a method that is certified by the National Glycohemoglobin Standardization Program (NGSP) (www.ngsp.org) and standardized or traceable to the Diabetes Control and Complications Trial (DCCT) reference assay.
Time Frame In 12, 24 and 36 weeks of the treatment as compared to the baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat set
Arm/Group Title Subetta Placebo
Hide Arm/Group Description:

Standard therapy of type II diabetes mellitus + Subetta (1 tablet 4 times a day).

Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).

Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type II diabetes mellitus

Standard therapy of type II diabetes mellitus + Placebo (1 tablet 4 times a day).

Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).

Placebo

Overall Number of Participants Analyzed 73 67
Mean (Standard Deviation)
Unit of Measure: percentage of HbA1c
12 weeks -0.53  (1.06) -0.01  (1.06)
24 weeks -0.54  (1.00) -0.07  (1.19)
36 weeks -0.54  (1.11) 0.15  (1.07)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Subetta, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments The p-value associated with "treatment" factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction.
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Change in Fasting Plasma Glucose
Hide Description Based on the data of biochemical analysis
Time Frame In 4, 12, 24 and 36 weeks of the treatment as compared to the baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Threat set
Arm/Group Title Subetta Placebo
Hide Arm/Group Description:

Standard therapy of type II diabetes mellitus + Subetta (1 tablet 4 times a day).

Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).

Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type II diabetes mellitus

Standard therapy of type II diabetes mellitus + Placebo (1 tablet 4 times a day).

Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).

Placebo

Overall Number of Participants Analyzed 73 67
Mean (Standard Deviation)
Unit of Measure: mmol / l
4 weeks -0.5  (2.6) -0.1  (3.2)
12 weeks 0.0  (2.5) 0.9  (3.3)
24 weeks 0.0  (2.9) 0.9  (4.1)
36 weeks 0.0  (3.1) 1.0  (3.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Subetta, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0426
Comments The p-value associated with "treatment" factor of changes from baseline to Week 4, 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction.
Method Mixed Models Analysis
Comments [Not Specified]
3.Secondary Outcome
Title Change in Average Daily Blood Glucose From a 7-point Patient Self-monitoring of Blood Glucose (SMBG)
Hide Description A 7-point patient self-monitoring of blood glucose (SMBG): three measurements of blood glucose before the meal; three measurements of postprandial blood glucose (1-2 h after the start of the meal) and one measurement at 3:00 a.m.
Time Frame During the whole study period (on weeks 4, 8, 12, 18, 24, 30 and 36 of the treatment) as compared to the baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat set. The SMBG in 3 patients (2 in the Subetta and 1 in the Placebo) was excluded from the analysis due to mistakes in diaries.
Arm/Group Title Subetta Placebo
Hide Arm/Group Description:

Standard therapy of type II diabetes mellitus + Subetta (1 tablet 4 times a day).

Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).

Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type II diabetes mellitus

Standard therapy of type II diabetes mellitus + Placebo (1 tablet 4 times a day).

Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).

Placebo

Overall Number of Participants Analyzed 71 66
Mean (Standard Deviation)
Unit of Measure: mmol / l
4 weeks -0.3  (1.5) -0.5  (1.8)
8 weeks -0.3  (1.6) -0.5  (1.7)
12 weeks -0.4  (1.7) -0.4  (2.1)
18 weeks -0.2  (1.6) -0.4  (1.6)
24 weeks -0.5  (1.6) -0.5  (1.7)
30 weeks -0.3  (1.7) -0.5  (1.5)
36 weeks -0.5  (1.9) -0.6  (1.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Subetta, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5990
Comments The p-value associated with "treatment" factor of changes from baseline to Week 4, 8, 12, 18, 24, 30 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction.
Method Mixed Models Analysis
Comments [Not Specified]
4.Secondary Outcome
Title Mean Value of C-peptide
Hide Description Blood samples (for measurement of fasting plasma glucose, concentrations of plasma C-peptide, total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides) are taken under standard conditions: after night break in food taking (at least 8 hours) and prior to administering of insulin morning dose (if patient receives intermediate insulin twice-daily), prior to any morning medicines intake (including the study drug, metformin, sulfonylurea derivatives, permitted concomitant therapy).
Time Frame In 12, 24 and 36 weeks of the treatment as compared to the baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat set.
Arm/Group Title Subetta Placebo
Hide Arm/Group Description:

Standard therapy of type II diabetes mellitus + Subetta (1 tablet 4 times a day).

Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).

Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type II diabetes mellitus

Standard therapy of type II diabetes mellitus + Placebo (1 tablet 4 times a day).

Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).

Placebo

Overall Number of Participants Analyzed 73 67
Mean (Standard Deviation)
Unit of Measure: pmol / l
0 week 615.3  (418.9) 607.6  (425.4)
12 weeks 628.3  (400.8) 607.7  (405.6)
24 weeks 643.3  (419.2) 641.6  (426.3)
36 weeks 589.6  (343.5) 540.0  (328.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Subetta, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6215
Comments The p-value associated with "treatment" factor of mean value at baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction.
Method Mixed Models Analysis
Comments [Not Specified]
5.Secondary Outcome
Title Changes in Lipids (Concentrations of Plasma Total Cholesterol, HDL Cholesterol, LDL Cholesterol and Triglycerides)
Hide Description Blood samples (for measurement of fasting plasma glucose, concentrations of plasma total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides) are taken under standard conditions: after night break in food taking (at least 12 hours) and prior to administering of insulin morning dose (prandial), prior to any morning medicines intake (including the study drug and permitted concomitant therapy).
Time Frame In 12, 24 and 36 weeks of the treatment as compared to the baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat set.
Arm/Group Title Subetta Placebo
Hide Arm/Group Description:

Standard therapy of type II diabetes mellitus + Subetta (1 tablet 4 times a day).

Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).

Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type II diabetes mellitus

Standard therapy of type II diabetes mellitus + Placebo (1 tablet 4 times a day).

Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).

Placebo

Overall Number of Participants Analyzed 73 67
Mean (Standard Deviation)
Unit of Measure: mmol / l
Total cholesterol (12 weeks) 0.1  (1.1) 0.1  (1.2)
Total cholesterol (24 weeks) 0.1  (1.2) 0.1  (0.9)
Total cholesterol (36 weeks) 0.3  (1.1) 0.0  (1.1)
HDL cholesterol (12 weeks) 0.0  (0.2) 0.0  (0.2)
HDL cholesterol (24 weeks) 0.0  (0.2) 0.0  (0.2)
HDL cholesterol (36 weeks) 0.0  (0.3) 0.0  (0.2)
LDL cholesterol (12 weeks) 0.1  (0.8) 0.0  (0.9)
LDL cholesterol (24 weeks) 0.1  (0.9) 0.1  (0.8)
LDL cholesterol (36 weeks) 0.2  (0.8) 0.1  (0.9)
Triglycerides (12 weeks) 0.2  (0.8) 0.2  (0.9)
Triglycerides (24 weeks) 0.1  (0.9) 0.0  (0.8)
Triglycerides (36 weeks) 0.1  (0.9) -0.1  (0.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Subetta, Placebo
Comments Analysis of Total cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6155
Comments The p-value associated with "treatment" factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction.
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Subetta, Placebo
Comments Analysis of HDL cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7507
Comments The p-value associated with "treatment" factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction.
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Subetta, Placebo
Comments Analysis of LDL cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4195
Comments The p-value associated with "treatment" factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction.
Method Mixed Models Analysis
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Subetta, Placebo
Comments Analysis of Triglycerides changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3609
Comments The p-value associated with "treatment" factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction.
Method Mixed Models Analysis
Comments [Not Specified]
6.Secondary Outcome
Title Changes in Dosage of Insulin (Basal Dose Insulin Measured in IU/Day)
Hide Description

Changes in basal insulin dose is based on the mean value of 3 consecutive measuring of level of fasting blood glucose.

  1. If value of fasting blood glucose at 7:00 AM on January 21, 2012 - 4.2 mmol/L, at 7:30 AM on January 22, 2012- 5.0 mmol/L, at 7:00 AM on January 23, 2012 4.8 mmol/L, then the mean level of blood glucose =4.7 mmol/L (4.2 +5.0 +4.8 divided by 3). It is not recommended to change the dose.
  2. If the mean value of fasting blood glucose is lower than 4.0 mmol/L and a patient shows unreasonable signs or symptoms of hypoglycemia, then dose of basal insulin should be reduced by 2 units.
  3. If value of fasting blood glucose for 3 consecutive days was ≥7 mmol/L, then dose of basal insulin should be increased by 2 units and more (depending on individual values).

Based on the same values investigator can change dose of per oral blood sugar-lowering drugs.

Time Frame In 36 weeks of the treatment as compared to the baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat
Arm/Group Title Subetta Placebo
Hide Arm/Group Description:

Standard therapy of type II diabetes mellitus + Subetta (1 tablet 4 times a day).

Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).

Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type II diabetes mellitus

Standard therapy of type II diabetes mellitus + Placebo (1 tablet 4 times a day).

Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).

Placebo

Overall Number of Participants Analyzed 73 67
Mean (Standard Deviation)
Unit of Measure: IU/day
-0.9  (2.4) 3.5  (9.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Subetta, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0605
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Changes in Dosage of Insulin (Basal Dose Insulin Measured in IU/ kg of Body Weight)
Hide Description

Changes in basal insulin dose is based on the mean value of 3 consecutive measuring of level of fasting blood glucose.

If value of fasting blood glucose at 7:00 AM on January 21, 2012 - 4.2 mmol/L, at 7:30 AM on January 22, 2012- 5.0 mmol/L, at 7:00 AM on January 23, 2012 4.8 mmol/L, then the mean level of blood glucose =4.7 mmol/L (4.2 +5.0 +4.8 divided by 3). It is not recommended to change the dose.

If the mean value of fasting blood glucose is lower than 4.0 mmol/L and a patient shows unreasonable signs or symptoms of hypoglycemia, then dose of basal insulin should be reduced by 2 units.

If value of fasting blood glucose for 3 consecutive days was ≥7 mmol/L, then dose of basal insulin should be increased by 2 units and more (depending on individual values).

Based on the same values investigator can change dose of per oral blood sugar-lowering drugs.

Time Frame In 36 weeks of the treatment as compared to the baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat set
Arm/Group Title Subetta Placebo
Hide Arm/Group Description:

Standard therapy of type II diabetes mellitus + Subetta (1 tablet 4 times a day).

Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).

Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type II diabetes mellitus

Standard therapy of type II diabetes mellitus + Placebo (1 tablet 4 times a day).

Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).

Placebo

Overall Number of Participants Analyzed 73 67
Mean (Standard Deviation)
Unit of Measure: IU/kg
-0.01  (0.03) 0.04  (0.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Subetta, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0726
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Patients With Changed Daily Dose of Per Oral Blood Sugar- Lowering Drugs
Hide Description [Not Specified]
Time Frame In 36 weeks of the treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat set
Arm/Group Title Subetta Placebo
Hide Arm/Group Description:

Standard therapy of type II diabetes mellitus + Subetta (1 tablet 4 times a day).

Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).

Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type II diabetes mellitus

Standard therapy of type II diabetes mellitus + Placebo (1 tablet 4 times a day).

Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).

Placebo

Overall Number of Participants Analyzed 73 67
Measure Type: Number
Unit of Measure: percentage of patients
4.1 9.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Subetta, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3108
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
9.Secondary Outcome
Title Changes in the Mean Absolute Value of Body Weight (kg)
Hide Description [Not Specified]
Time Frame In 36 weeks of the treatment as compared to the baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat set. Data on body weight in one patient from the placebo group were absent
Arm/Group Title Subetta Placebo
Hide Arm/Group Description:

Standard therapy of type II diabetes mellitus + Subetta (1 tablet 4 times a day).

Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).

Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type II diabetes mellitus

Standard therapy of type II diabetes mellitus + Placebo (1 tablet 4 times a day).

Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).

Placebo

Overall Number of Participants Analyzed 73 66
Mean (Standard Deviation)
Unit of Measure: kg
-0.1  (2.2) 0.4  (3.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Subetta, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2934
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
10.Secondary Outcome
Title Changes in the Mean Absolute Value of Body Mass Index (BMI) (kg/m^2)
Hide Description [Not Specified]
Time Frame baseline and 36 weeks of the treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat set. Data on body weight in one patient from the placebo group were absent
Arm/Group Title Subetta Placebo
Hide Arm/Group Description:

Standard therapy of type II diabetes mellitus + Subetta (1 tablet 4 times a day).

Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).

Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type II diabetes mellitus

Standard therapy of type II diabetes mellitus + Placebo (1 tablet 4 times a day).

Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).

Placebo

Overall Number of Participants Analyzed 73 66
Mean (Standard Deviation)
Unit of Measure: kg/m^2
-0.04  (0.78) 0.14  (1.33)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Subetta, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3410
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
11.Secondary Outcome
Title Satisfaction of Diabetes Treatment Based on Diabetes Treatment Satisfaction Questionnaire Data
Hide Description

The Diabetes Treatment Satisfaction Questionnaire allows to assess the degree of satisfaction with treatment for diabetes and its complications - retinopathy and nephropathy, how patients' satisfaction and perceived hyper- and hypoglycemia have changed compared to the initial period (before the treatment).

The Diabetes Treatment Satisfaction Questionnaire contains six items scored on 7-point scales from +3 (equals "very satisfied") to -3 (equals "very dissatisfied"), with 0 (equals "no change"). These are summed to produce a total Treatment Satisfaction score. Two questions concerning "Perceived Hyperglycaemia" and "Perceived Hypoglycaemia" respectively, are calculated separately. According to these two items, low scores represent good perceived blood glucose control (+3 means "most of the time" of Hyperglycaemia or Hypoglycaemia whereas -3 means "none of the time" of Hyperglycaemia or Hypoglycaemia).

Time Frame In 36 weeks of the treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat set. 8 patients (6 in the Subetta group and 2 in the Placebo group) was excluded from the analysis due to lake of questionnaires.
Arm/Group Title Subetta Placebo
Hide Arm/Group Description:

Standard therapy of type II diabetes mellitus + Subetta (1 tablet 4 times a day).

Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).

Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type II diabetes mellitus

Standard therapy of type II diabetes mellitus + Placebo (1 tablet 4 times a day).

Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).

Placebo

Overall Number of Participants Analyzed 67 65
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Satisfaction 9.8  (5.7) 8.3  (6.1)
Hyperglycemia -1.1  (1.6) -0.9  (1.7)
Hypoglycemia -1.1  (1.5) -1.0  (1.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Subetta, Placebo
Comments Satisfaction
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1577
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Subetta, Placebo
Comments Hyperglycemia
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5262
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Subetta, Placebo
Comments Hypoglycemia
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7417
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Adverse/Serious adverse events were registered during 36 weeks of therapy and 30 days after the end of therapy.
Adverse Event Reporting Description Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=148, Safety Population)
 
Arm/Group Title Subetta Placebo
Hide Arm/Group Description

Standard therapy of type II diabetes mellitus + Subetta (1 tablet 4 times a day).

Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).

Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type II diabetes mellitus

Standard therapy of type II diabetes mellitus + Placebo (1 tablet 4 times a day).

Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).

Placebo

All-Cause Mortality
Subetta Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Subetta Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/76 (1.32%)   1/72 (1.39%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Brain tumor NOS  1  0/76 (0.00%)  1/72 (1.39%) 
Nervous system disorders     
Brain stem stroke  1  1/76 (1.32%)  0/72 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Subetta Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   22/76 (28.95%)   24/72 (33.33%) 
Blood and lymphatic system disorders     
hypochromic anaemia  1  0/76 (0.00%)  1/72 (1.39%) 
Eye disorders     
retinal angiopathy  1  1/76 (1.32%)  0/72 (0.00%) 
Diabetic edematous maculopathy  1  1/76 (1.32%)  0/72 (0.00%) 
Edema of the upper eyelid of the right eye  1  1/76 (1.32%)  0/72 (0.00%) 
Gastrointestinal disorders     
duodenitis  1  0/76 (0.00%)  1/72 (1.39%) 
burning tongue  1  0/76 (0.00%)  1/72 (1.39%) 
epigastric burning  1  0/76 (0.00%)  1/72 (1.39%) 
Periodic pain in the left hypochondrium  1  3/76 (3.95%)  0/72 (0.00%) 
Periodic dull aching pain in the right hypochondrium  1  1/76 (1.32%)  0/72 (0.00%) 
Nausea  1  1/76 (1.32%)  0/72 (0.00%) 
Drawing pains in the right hypochondrium  1  0/76 (0.00%)  1/72 (1.39%) 
chronic gastritis  1  0/76 (0.00%)  1/72 (1.39%) 
chronic colitis  1  0/76 (0.00%)  1/72 (1.39%) 
Chronic parenchymal pancreatitis  1  1/76 (1.32%)  1/72 (1.39%) 
Chronic hemorrhagic gastritis  1 [1]  1/76 (1.32%)  0/72 (0.00%) 
irritable bowel syndrome  1  1/76 (1.32%)  0/72 (0.00%) 
Edema of the lower lip  1  1/76 (1.32%)  0/72 (0.00%) 
General disorders     
esurience  1  1/76 (1.32%)  0/72 (0.00%) 
Complaints about general fatigue, a feeling of total severity and swelling  1  1/76 (1.32%)  0/72 (0.00%) 
Hepatobiliary disorders     
Fatty liver hepatosis  1  1/76 (1.32%)  1/72 (1.39%) 
Immune system disorders     
allergic reaction  1  0/76 (0.00%)  1/72 (1.39%) 
Infections and infestations     
bilateral lacunar tonsillitis  1  1/76 (1.32%)  0/72 (0.00%) 
Asymptomatic bacteriuria  1  0/76 (0.00%)  1/72 (1.39%) 
upper respiratory infection  1  1/76 (1.32%)  4/72 (5.56%) 
acute respiratory infection  1  4/76 (5.26%)  10/72 (13.89%) 
upper respiratory tract infection  1  3/76 (3.95%)  0/72 (0.00%) 
acute pneumonia  1  1/76 (1.32%)  0/72 (0.00%) 
pulpitis  1  0/76 (0.00%)  1/72 (1.39%) 
rhinitis  1  1/76 (1.32%)  0/72 (0.00%) 
rhinosinusitis  1  1/76 (1.32%)  0/72 (0.00%) 
Erysipelas of the right lower leg  1  0/76 (0.00%)  1/72 (1.39%) 
pharyngitis  1  1/76 (1.32%)  0/72 (0.00%) 
Injury, poisoning and procedural complications     
Fracture of radial head to the right  1  0/76 (0.00%)  1/72 (1.39%) 
Fracture of terminal phalanx of 5th toe of left foot  1  0/76 (0.00%)  1/72 (1.39%) 
Investigations     
Increased blood pressure  1  4/76 (5.26%)  2/72 (2.78%) 
rapid pulse  1  0/76 (0.00%)  1/72 (1.39%) 
Metabolism and nutrition disorders     
Fasting hyperglycemia  1  1/76 (1.32%)  0/72 (0.00%) 
hypercholesterinemia  1  0/76 (0.00%)  1/72 (1.39%) 
Dyslipidemia, worsening  1  0/76 (0.00%)  1/72 (1.39%) 
Increased appetite  1  0/76 (0.00%)  1/72 (1.39%) 
Musculoskeletal and connective tissue disorders     
Pain in the knee joints  1  1/76 (1.32%)  0/72 (0.00%) 
melosalgia  1  1/76 (1.32%)  0/72 (0.00%) 
Pain in the lumbar spine  1  1/76 (1.32%)  1/72 (1.39%) 
back pain  1  1/76 (1.32%)  0/72 (0.00%) 
cervical vertebral osteochondrosis  1  1/76 (1.32%)  0/72 (0.00%) 
Nervous system disorders     
headache  1  0/76 (0.00%)  1/72 (1.39%) 
occipital headache  1  1/76 (1.32%)  0/72 (0.00%) 
Diabetic distal sensory lower limb polyneuropathy, worsening  1  1/76 (1.32%)  0/72 (0.00%) 
Increased numbness in the fingers, feets  1  1/76 (1.32%)  0/72 (0.00%) 
Psychiatric disorders     
Tingling in the region of the heart that occurs after excitement on a background of a stressful situ  1  1/76 (1.32%)  0/72 (0.00%) 
Twitching of the right eye against a background of stress  1  0/76 (0.00%)  1/72 (1.39%) 
phobic disorder  1  1/76 (1.32%)  0/72 (0.00%) 
Skin and subcutaneous tissue disorders     
skin itch  1  1/76 (1.32%)  0/72 (0.00%) 
Urticaria  1  1/76 (1.32%)  0/72 (0.00%) 
A papular rash in the area of the forearms, hands, right knee joint  1  1/76 (1.32%)  0/72 (0.00%) 
Urticaria on the extremities  1  1/76 (1.32%)  0/72 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
[1]
Chronic hemorrhagic gastritis, associated with Helicobacter, exacerbation
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Putilovskiy, MD, PhD, Clinical Research and Medical Information Director
Organization: Materia Medica Holding
Phone: +74952761571 ext 302
EMail: PutilovskiyMA@materiamedica.ru
Layout table for additonal information
Responsible Party: Materia Medica Holding
ClinicalTrials.gov Identifier: NCT01868646    
Other Study ID Numbers: MMH-SU-004
First Submitted: May 27, 2013
First Posted: June 4, 2013
Results First Submitted: December 28, 2017
Results First Posted: March 4, 2019
Last Update Posted: May 31, 2019